What is the OIG’s guidance on PAP fraud and abuse?
In 2005, the OIG issued additional guidance in a special advisory bulletin that considered fraud and abuse concerns associated with PAPs.
Are patient assistance programs (Paps) for drug manufacturers worth it?
We are all familiar with the patient assistance programs (PAPs) primarily sponsored by drug manufacturers or a partner organization and generally consider them a good thing for assisting patients with high out-of-pocket costs for expensive specialty drugs, especially in this era of high-deductible insurance plans.
How do I report health care fraud and waste?
Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement can be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).
How much did Amgen pay to resolve the government’s healthcare fraud allegations?
Amgen has agreed to pay $24.75 million to resolve the government’s allegations. The government’s resolution of these matters illustrates the government’s emphasis on combating healthcare fraud.
What is the complaint against PSI?
What is the purpose of PAPs?
What is a rescinded OIG letter?
What is the OIG opinion on CVC?
What should stakeholders do with PAPs?
What are the two aspects of PAP?
What is the focus of PAPs?
See 4 more
About this website
Is patient assistance program legitimate?
Patient assistance programs (PAPs) are usually sponsored by pharmaceutical manufacturers and are promoted as a safety net for Americans who have no health insurance or are underinsured.
Why do pharmaceutical companies have patient assistance programs?
They increase demand, allow companies to charge higher prices, and provide public-relations benefits. Assistance programs are an especially attractive proposition for firms that sell particularly costly drugs. Faced with high out-of-pocket costs, some patients may decide against taking an expensive medication.
Is Prescription Assistance 123 legitimate?
The answer is yes. We are a legitimate service that is offered to those who really need our help. Our employees always strive for excellence and treat confidentiality and HIPPA regulations with the highest importance, as it is our duty to uphold them on behalf of our clients.
How does the pan foundation work?
What does PAN cover? Our 12-month grants offer financial assistance for out-of-pocket medication costs, including co-pays, health insurance premiums, and transportation costs associated with medical care. Co-pay funds: assistance with deductibles, co-pays, and coinsurance for medications.
What is PAP in pharma?
Pharmaceutical manufacturers may sponsor patient assistance programs (PAPs) that provide financial assistance or drug free product (through in-kind product donations) to low income individuals to augment any existing prescription drug coverage.
Is Needy Meds legitimate?
NeedyMeds is a national non-profit organization that maintains a website of free information on programs that help people who can't afford medications and healthcare costs. More than 1.3 million patients, family members, healthcare professionals, social workers and patient advocates use the NeedyMeds website each year.
Is prescription lifeline a legitimate company?
It is a scam. In December of 2020 I found out I had given this pharmacy years of my money for a medicine I could have gotten straight from the drug manufacturer for free.
What is a patient support program?
A patient assistance or support programs (PAPs or PSPs) exist to get you timely access to medication and to help you stay on track of your therapy. Being diagnosed with a complex disease or condition may come with unexpected financial burden and a need to better understand treatment options and next steps.
What is the Florida prescription assistance program?
Description: Florida Rx Card is the free statewide prescription assistance program available to all Florida residents. The program was launched in August 2007 to help uninsured and underinsured Florida residents with their prescription medication costs.
Patient Assistance Programs: The Good, the Bad, and the Ugly
We are all familiar with the patient assistance programs (PAPs) primarily sponsored by drug manufacturers or a partner organization and generally consider them a good thing for assisting patients with high out-of-pocket costs for expensive specialty drugs, especially in this era of high-deductible insurance plans.
Emerging Enforcement Trends For Patient Support Programs
This article by former partner Brett Friedman, counsel Alison Fethke and associate Jamie Darch was published by Law360 on May 15, 2018. Over the past year, a growing number of governmental investigations and settlements call into question the practice of pharmaceutical companies donating to independent charities that provide financial assistance with out-of-pocket drug costs to patients.
Patient Assistance Programs - Frequently Asked Questions
What steps do you need to take? Yes. Although eligibility differs from program to program, they all have three specific criteria in common. Income: To qualify for any patient assistance program, your total household income must be less than 200% of the Federal Poverty Level. Prescription Coverage: Prescription assistance programs require that you do not currently subscribe to private or public ...
HHS OIG Approves Narrowly-Tailored Patient Assistance Program
On Jan. 15, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued Advisory Opinion No. 20-02 which addresses whether a pharmaceutical manufacturer providing financial assistance to patients constitutes grounds for the imposition of sanctions under the civil monetary penalty provision prohibiting inducements to beneficiaries, section 1128A(a)(5) of the ...
What is PAP in Medicare?
As explained in the Bulletin, arrangements through which a pharmaceutical manufacturer would use a PAP it operates or controls to subsidize its own products that will be payable by Medicare Part D present a heightened risk of fraud and abuse .
Who is the Inspector General of HHS?
202-619-0088. Washington, DC – HHS Inspector General Daniel R. Levinson today released a Special Advisory Bulletin providing guidance on the application of OIG fraud and abuse laws to patient assistance programs (PAPs) that offer assistance in obtaining outpatient prescription drugs to financially needy Medicare beneficiaries who enroll in ...
Can pharmaceutical companies make donations to PAPs?
For example, the Bulletin, reflecting long-standing OIG guidance, makes clear that pharma ceutical manufacturers can make cash donations to bona fide independent charity PAPs that are not affiliated with a manufacturer and operate without regard to donor interests, providing appropriate safeguards exist. These programs are typically operated by patient advocacy and support organizations.
Can OIG prevent Medicare from helping uninsured patients?
Finally, the Bulletin makes clear that nothing in any OIG laws or regulations prevents pharmaceutical manufacturers or others from helping uninsured patients and Medicare beneficiaries who have not enrolled in Part D with their outpatient prescription drugs.
Why is not participating in PAP bad?
In fact, to not participate in a PAP can be interpreted as overpaying for a drug, somewhat like paying the list price for a new car. Of course, the exclusion of governmental insurance plans is unfortunate because these patients are often the ones in greatest need of financial assistance.
Why is it important to connect patients with PAPs?
Many health care systems have gone so far as to develop organized programs to connect patients with PAPs as a means of enhancing access to medications and reducing their financial burden. This is also potentially beneficial for the institution because it reduces bad debt . At my organization, we have a new job category called medication access specialists, who, among other things, are responsible for connecting patients to PAPs and helping families and patients navigate the sometimes confusing process. Therefore, at the micro level, this is a good thing.
How much is the maximum out of pocket cost for PAP?
For example, if the maximum allowable on the PAP is $15,000 per year, the patient’s out-of-pocket cost will be $1250 per month . That is, the co-pay becomes very flexible, based on the dollars available from the PAP, and the company takes every dollar available. Thus, if the patient does not sign up to participate in the maximizer program, their outof- pocket cost would be $15,000 per year under this example, because it is their “co-pay” for a nonessential health service. Under the maximizer arrangement, the patient’s out-of-pocket cost for treatment is $0, so there is no contribution to the deductible or maximum outof- pocket cost from their drug therapy.
Can high cost drug therapy be used to eliminate deductible?
If patients on high-cost drug therapy know they are not assum ing that financial risk because of being able to use PAP money to eliminate their deductible, one could argue that the system is being gamed to some extent. In response, accumulator programs entered the arena.
Can you use PAP money to pay down deductible?
Understandably, employers and payers do not appreciate that PAP dollars are being used by patients to pay down their deductible and maximum out-of-pocket expense while the plan experiences escalating pharmacy benefit costs because of these expensive agents.
Who should be mindful of PAP?
Any person or entity wishing to implement or participate in a PAP should be mindful of this previous guidance and the limited situations in which the OIG has blessed such arrangements (as in Advisory Opinion 20-02).
What is OIG opinion 20-02?
On Jan. 15, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued Advisory Opinion No. 20-02 which addresses whether a pharmaceutical manufacturer providing financial assistance to patients constitutes grounds for the imposition of sanctions under the civil monetary penalty provision prohibiting inducements to beneficiaries, section 1128A (a) (5) of the Social Security Act (the Act), the exclusion authority at section 1128 (b) (7) of the Act or the civil monetary penalty provision at section 1128A (a) (7) of the Act. These sections relate to the commission of acts described in section 1128B (b) of the Act, the federal anti-kickback statute.
What is a drug infusion requestor?
Under the arrangement, the requestor assists eligible patients, between the ages of 18-25 years old, and up to two caregivers with travel, lodging, meals and certain out-of-pocket expenses they incur during and after the patient’s drug infusion. For patients 26 and older, the requestor provides the same support for a patient and one caregiver. The requestor does not provide assistance with patient travel or expenses associated with initial patient consultations, leukapheresis or follow-up visits beyond the post-infusion monitoring required by the drug’s prescribing information. The requestor does not authorize lodging under the arrangement to a patient treated by a center when the requestor has knowledge that the patient is eligible to receive lodging from the center, and such lodging is available for that patient’s use. The requestor also certified that it does not advertise the arrangement. Patients do not learn about, or become eligible for, the arrangement until they have been diagnosed with the appropriate disease and are prescribed treatment with the drug. Under the arrangement, the requestor provides reimbursement for gas and tolls or arranges for transportation via bus, rail, rental car or air travel for a patient and caregiver (s) to and from the closest center accepting patients using a third-party travel vendor.
What is an eligible patient?
Eligible patients are patients who have been prescribed the drug for an FDA-approved indication and have a household income that does not exceed 600 percent of the federal poverty level, who live more than two hours driving distance or 100 miles from the nearest center accepting patients and who have no insurance for non-emergency medical travel. The requestor offers the arrangement to eligible patients regardless of their provider or insurance status. To participate in the arrangement, the patient and caregiver (s) must agree not to request reimbursement from federal health care programs for costs covered under the arrangement. The requestor certified that it does not bill or otherwise shift the costs of the arrangement to the federal health care programs.
How long does a patient have to be monitored after an infusion?
Patients receive assistance for four weeks post-infusion; however, if the patient’s physician determines that it is medically necessary to monitor the patient for risks of negative outcomes for longer than four weeks , the requestor provides assistance for the duration of monitoring deemed necessary by the physician.
Can the OIG impose administrative sanctions?
The OIG advised that it will not impose administrative sanctions under the above-listed sections of the Act for the specific scenario described but noted that similar circumstances could create prohibited remuneration under the anti-kickback statute if the requisite intent to induce or reward referrals of federal health care program business were present.
Do you have to agree to reimburse for a health care arrangement?
To participate in the arrangement, the patient and caregiver (s) must agree not to request reimbursement from federal health care programs for costs covered under the arrangement. The requestor certified that it does not bill or otherwise shift the costs of the arrangement to the federal health care programs.
What is the alleged violation of the OIG?
According to the OIG, the alleged violations “materially increased the risk that [the charity] served as a conduit for financial assistance from a [drug company] donor to a patient,” and thus increased the risk that the charity’s Medicare patients would be steered to that company’s federally reimbursable drugs.
What is the OIG opinion on Caring Voice?
The Office of Inspector General’s (OIG) advisory opinion protected Caring Voice Coalition from liability under the Anti-Kickback Statute for its work providing financially needy Medicare patients with premium and cost-sharing assistance. Drug companies are the primary donors to almost all charity patient assistance programs (PAPs), including Caring Voice Coalition, while some drug companies also create their own charity PAPs. The OIG’s 2006 opinion issued to Caring Voice Coalition was fact-specific, as are all advisory opinions, and in this case was predicated on commitments the charity made to implement certain safeguards regarding contributions from donors and grants to beneficiaries.
What is the OIG CIA?
The December 2017 OIG CIA was announced as part of a settlement between United Therapeutics and the Department of Justice (DOJ), which alleged that United Therapeutics induced patients to purchase its drugs by donating to charity PAPs over which it exerted some control.
Is Caring Voice Coalition offering financial assistance?
Last week, one of the largest charity patient assistance programs in the country, Caring Voice Coalition, announced that it would not be offering financial assistance for any of its disease funds in 2018.
Is United Therapeutics in the CIA?
Subsequent to entering the CIA with United Therapeutics, and on the same day Caring Voice Coalition announced it would not offer financial assistance in 2018, OIG released a letter it sent to a drug company trade group, dated January 4, 2018.
Why is Gilead Sciences limiting its patient assistance program?
Earlier this year, Gilead Sciences limited its patient-assistance program for its stratospherically priced hepatitis C drugs Sovaldi and Harvoni, in an effort to squeeze insurers. As we reported earlier, the drugs work well, but because they cost nearly $100,000 per treatment, insurers were limiting them to only the sickest hep-C patients.
Why do private insurers and Medicare officials dislike these programs?
As that battle shows, private insurers and Medicare officials dislike these programs because subsidizing the patients undermines what may be their most important tool for controlling healthcare costs, which is steering patients to low-cost alternative drugs or generics. The patients are immunized against their small share of the cost, but the insurers and government still have to pick up the rest.
Why did Gilead hold hepatitis C patients hostage?
In effect, the AIDS Healthcare Foundation protested, saying Gilead was “holding hepatitis C patients hostage as a negotiating strategy with health insurers for drugs that they ridiculously overpriced in the first place.”.
Why did Gilead shut down assistance?
Gilead hoped that covering patient co-pays would pressure the insurers into allowing broader use of the drugs. When that didn’t happen, the firm shut down assistance for enrollees of insurers that were still applying restrictions; the hope plainly was that patients would scream at the insurers. In effect, the AIDS Healthcare Foundation protested, saying Gilead was “holding hepatitis C patients hostage as a negotiating strategy with health insurers for drugs that they ridiculously overpriced in the first place.”
What charity was accused of having a relationship with Questcor?
The Chronic Disease Fund , a major charity in the field, was accused in 2013 of having too cozy a relationship with Questcor, the maker of a multiple sclerosis drug sold for $28,000 per vial, which was covered with CDF assistance. (The head of the charity stepped down after the relationship became public.)
Can insurers help patients who can't afford their share of drugs?
The suspect nature of these programs doesn’t solve the problem of how to get the drugs to patients who can’t afford their share. But that’s not an insurmountable problem. For one thing, insurers don’t object so much to assistance programs for drugs that truly are uniquely effective, and at prices that are rational; their big problem is with expensive brand names that are just as effective as alternative treatments, or even inferior.
Does the VA pay less for drugs than Medicare?
The VA has used this authority to exclude many of the me-too drugs that drive healthcare costs higher. Frakt calculated in 2011 that the VA paid 40% less for drugs than Medicare, while covering 59% of the most popular 200 drugs, compared with Medicare’s 85%. The change, he estimated, could save Medicare more than $14 billion a year. It might have a considerable multiplier effect nationwide by providing a truly effective benchmark for drug prices.
What is the number to report healthcare fraud?
Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement can be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).
How much did Amgen pay for False Claims Act?
(Astellas) and Amgen Inc. (Amgen) – have agreed to pay a total of $124.75 million to resolve allegations that they each violated the False Claims Act by illegally paying the Medicare copays for their own products, through purportedly independent foundations that the companies used as mere conduits.
What is a partial payment for Medicare?
When a Medicare beneficiary obtains a prescription drug covered by Medicare, the beneficiary may be required to make a partial payment, which may take the form of a copayment, coinsurance, or a deductible (collectively “copays”). Congress included copay requirements in the Medicare program, in part, to serve as a check on health care costs, including the prices that pharmaceutical manufacturers can demand for their drugs. The Anti-Kickback Statute prohibits a pharmaceutical company from offering or paying, directly or indirectly, any remuneration — which includes money or any other thing of value — to induce Medicare patients to purchase the company’s drugs. This prohibition extends to the payment of patients’ copay obligations.
Did Astellas pay $100 million for Xtandi?
The government further alleged that, during the time that the ARI funds were open, Astellas promoted the existence of the ARI funds as an advantage for Xtandi over competing drugs in an effort to persuade medical providers to prescribe Xtandi. Astellas has agreed to pay $100 million to resolve the government’s allegations.
Is Astellas an ARI only fund?
In July 2013, both foundations opened ARI-only copay funds; Astellas was the sole donor to both funds. The government alleged that Astellas knew that Xtandi would likely account for the vast majority of utilization from each fund, and, in fact, Medicare patients taking Xtandi received nearly all of the copay assistance from the two ARI funds.
Did Amgen donate to Onyx?
The government alleged that Onyx was the sole donor to this travel fund and that Amgen, after integrating Onyx into its operations in 2015, continued to donate to the fund. The foundation also operated a second fund that covered copays for multiple myeloma drugs, including Kyprolis.
Who conducted the Massachusetts investigation?
These investigations were conducted by the Department of Justice’s Civil Division and the U.S. Attorney’s Office for the District of Massachusetts, in conjunction with the Department of Health and Human Services, Office of Inspector General; and the FBI. The U.S. Postal Inspection Service also assisted with the investigation.
What is the complaint against PSI?
district court for the Eastern District of Virginia, alleging that the OIG’s recent guidance prohibits PSI’s protected free speech with donors and potential donors, jeopardizing PSI’s ability to operate. [29] .
What is the purpose of PAPs?
Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) has continually acknowledged that properly structured PAPs can provide important “safety net assistance” to patients with limited financial means who cannot afford necessary drugs. This Client Alert provides a comprehensive review ...
What is a rescinded OIG letter?
However, on November 28, 2017, the OIG issued a letter rescinding Advisory Opinion 06-04 (“Rescission Letter”), based on the charity’s “failure to fully, completely, and accurately disclose all relevant and material facts to OIG,” and CVC’s alleged failure to comply with certain factual certifications made to the OIG. Specifically, the OIG states that it determined that the charity “provided patient-specific data to one or more donors that would enable the donor (s) to correlate the amount and frequency of their donations with the number of subsidized prescriptions or orders for their products, and (ii) allowed donors to directly or indirectly influence the identification or delineation of Requestor’s disease categories.” [14] The Rescission Letter indicates that CVC’s failure to comply with the certifications “materially increased the risk” that CVC served as a conduit for financial assistance from a drug manufacturer donor to a patient, and thus inappropriate steerage to the donor’s drugs.
What is the OIG opinion on CVC?
In December 2015, the OIG published a Modified Advisory Opinion 06-04, following the OIG’s request that CVC certify compliance with the additional factors outlined in the 2014 Special Advisory Bulletin. The Modified Advisory Opinion stated that CVC had certified compliance to each additional factor, and further that CVC had proposed additional modifications to its current operations. [13] The OIG concluded in the Modified Advisory Opinion 06-04 that CVC’s PAP was sufficiently low risk and the OIG would not impose CMPs or sanctions on CVC under the AKS.
What should stakeholders do with PAPs?
Stakeholders should also closely monitor federal and state legislative policy developments regarding PAPs, including copayment assistance and product coupons. K&L Gates regularly advises clients on health care fraud and abuse risk mitigation and compliance matters and facilitate stakeholder engagement with Congress and state legislators and HHS.
What are the two aspects of PAP?
The OIG has indicated that PAPs generally have two “remunerative aspects” that require scrutiny under the AKS: i) donor contributions , which the OIG stated can be analyzed as indirect remuneration to patients , and ii) financial assistance remuneration provided directly to patients. The OIG states that the AKS could be violated “if a donation is made to a PAP to induce the PAP to recommend or arrange for the purchase of the donor’s federally reimbursable items,” as well as if a PAP’s grant of financial assistance to a patient is made “to influence the patient to purchase (or induce the patient’s physician to prescribe) certain items.” [5]
What is the focus of PAPs?
Ultimately, data sharing and communication between charity PAPs and donors appears to be the key area of focus for OIG, DOJ, and IRS enforcement. If such communication and data sharing is prohibited, whether by state statute or federal regulatory enforcement, it is remains to be seen whether PAPs will continue to operate as they are currently structured. In any event, it is incumbent upon interested parties to stay abreast of changes in the law and developing enforcement trends, and to continually monitor and update their compliance programs accordingly. For example, given the amount of scrutiny applied to coordination between the business and charitable giving arms of medical product manufacturers, compliance programs should be actively examining all intra-firm transactions to assure that no improper influence is being exerted over communications with and donations to charity PAPs.
